Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
Membrane guided tissue regeneration is new biological concept. The basic theory of this concept includes the belief that during the healing process of wound, the different cells will show different speed of cell migration and regeneration in the wound. If an appropriate membrane being placed to form a mechanical barrier, so that only the needed cells can grow into that area and prevent others from going in, thus resulting in the creation of a guided area where the needed cells can undergo proliferation and differentiation under protection in completing an ideal tissue regeneration and repair. In this article, the experimental researches on the application of membrane guided tissue regeneration in the repair of tubular bone defects, skull defects and faciomaxillary defects were reviewed from literatures, and the degradable and non-degradable materials were introduced, particularly. The pros and cons of this method and the materials were evaluated. It is believed that this technique will push forward the progress in bone biology and reconstructive surgery.
Objective To investigate the effectiveness of sacroiliac screw implantation assisted by three-dimensional (3D) printed faceted honeycomb guide plate in the treatment of posterior pelvic ring fracture. Methods The clinical data of 40 patients with posterior pelvic ring fractures treated with sacroiliac screw implantation between December 2019 and December 2022 were retrospectively analyzed. Among them, 18 cases were treated with sacroiliac screws fixation assisted by 3D printed faceted honeycomb guide plate (guide plate group), and 22 cases were treated with sacroiliac screws percutaneously fixation under fluoroscopy (conventional group). There was no significant difference in baseline data (P>0.05) such as gender, age, time from injury to operation, and Dennis classification between the two groups. The implantation time, frequency of C-arm X-ray fluoroscopy, frequency of guide pin adjustment of each sacroiliac screw, and postoperative complications and bone healing were recorded. Majeed score was used to evaluate the functional recovery at 6 months after operation, and CT was used to observe whether the screw penetrated the bone cortex. The deviation between the virtual position and the actual position of the screw tip, the sacral foramen, and the screw entry point was measured on the sagittal CT images of the guide plate group. Results The number of screws implanted in S1 and S2 vertebral bodies was 14 and 16 respectively in the guide plate group, and 17 and 18 respectively in the conventional group. The implantation time of each sacroiliac screw, the frequency of C-arm X-ray fluoroscopy, and the frequency of guide pin adjustment in S1, S2, and all vertebrae in the guide plate group were significantly less than those in the conventional group (P<0.05). Patients in both groups were followed up 8-48 months, with an average of 19.7 months. There was no incision infection, screw displacement, or internal fixation loosening in both groups. Callus growth was observed in all patients at 12 weeks after operation, and bone healing was achieved in all patients. The healing time ranged from 12 to 24 weeks, with an average of 15.7 weeks. No sacroiliac screw penetrated the bone cortex in the guide plate group; 2 patients in the conventional group had sacroiliac screws penetrating the bone cortex without damaging blood vessels or nerves. In the guide plate group, the deviation between the virtual position and the actual position of the screw tip, the sacral foramen, and the screw entry point were (2.91±1.01), (2.10±0.74), and (1.67±0.70) mm, respectively, with an average deviation of (2.19±1.22) mm. There was no significant difference in Majeed function evaluation between the two groups at 6 months after operation (P>0.05). Conclusion The application of 3D printed faceted honeycomb guide plate in sacroiliac screw implantation for posterior pelvic ring fracture can shorten the screw implantation time, reduce the frequency of fluoroscopy and guide pin adjustment, and reduce the risk of screw penetration through the bone cortex.
The 8th World International Symposium on the Diabetic Foot (ISDF) Conference which was sponsored by the International Working Group on Diabetic Foot (IWGDF) was held in the Hague between May 22nd and May 25th, 2019. The conference issued the 2019 IWGDF guidelines on the prevention and management of diabetic foot disease. The update to the 2015 edition of the guidelines involves the following 6 chapters: prevention of foot ulcers in patients with diabetes; offloading foot ulcers in patients with diabetes; diagnosis, prognosis, and management of peripheral arterial disease in patients with a foot ulcer and diabetes; diagnosis and treatment of foot infection in patients with diabetes; interventions to enhance healing of foot ulcers in patients with diabetes; classification of diabetic foot ulcers. This guideline has been changed more than the previous edition. In this paper, the guidelines will be interpreted to provide cutting-edge information for domestic diabetic foot researchers.
There is an increase in published studies relevant to the development of patient version of guidelines (PVGs). We reviewed, summarised and analysed the current developments in this field, with the aim of informing domestic scholars of the factors to consider when developing quality PVGs. We proposed three recommendations: (1) the concept of patient guidelines needs to be better defined; (2) a platform for the dissemination of PVGs should be established to support their implementation; and (3) a standardised PVGs development methodology should be developed to ensure the quality of the PVGs.
ObjectiveTo investigate the effectiveness of digital three-dimensional (3D) printing osteotomy guide plate assisted total knee arthroplasty (TKA) in treatment of knee osteoarthritis (KOA) patients with femoral internal implants. Methods The clinical data of 55 KOA patients who met the selection criteria between July 2021 and October 2023 were retrospectively analyzed. Among them, 26 cases combined with femoral implants were treated with digital 3D printing osteotomy guide plate assisted TKA (guide plate group), and 29 cases were treated with conventional TKA (control group). There was no significant difference in gender, age, body mass index, side, Kellgren-Lawrence classification, preoperative visual analogue scale (VAS) score, Hospital for Special Surgery (HSS) knee score, knee range of motion, and other baseline data between the two groups (P>0.05). The operation time, intraoperative blood loss, incision length, postoperative first ambulation time, surgical complications; VAS score, knee HSS score, knee range of motion before operation, at 1 week and 3 months after operation, and at last follow-up; distal femoral lateral angle, proximal tibial medial angle, hip-knee-ankle angle and other imaging indicators at last follow-up were recorded and compared between the two groups. ResultsThe operation time, incision length, intraoperative blood loss, and postoperative first ambulation time in the guide plate group were significantly lower than those in the control group (P<0.05). In the control group, there were 1 case of incision rupture and bleeding and 1 case of lower limb intermuscular venous thrombosis, which was cured after symptomatic treatment. There was no complication such as neurovascular injury, incision infection, or knee prosthesis loosening in both groups. Patients in both groups were followed up 12-26 months, with an average of 16.25 months. The VAS score, HSS score, and knee range of motion improved at each time point after operation in both groups, and further improved with time after operation, the differences were significant (P<0.05). The above indicators in the guide plate group were significantly better than those in the control group at 1 week and 3 months after operation (P<0.05), and there was no significant difference between the two groups at last follow-up (P>0.05). At last follow-up, the distal femoral lateral angle, the proximal tibial medial angle, and the hip-knee-ankle angle in the guide plate group were significantly better than those in the control group (P<0.05). Conclusion The application of digital 3D printing osteotomy guide plate assisted TKA in the treatment of KOA patients with femoral implants can simplify the surgical procedures, overcome limitations of conventional osteotomy guides, reduce surgical trauma, achieve individualized and precise osteotomy, and effectively restore lower limb alignment and knee joint function.
ObjectivesTo evaluate the quality of evidence-based guidelines for the treatment of female stress urinary incontinence, so as to provide evidence for clinical stress urinary incontinence management research.MethodsWebsite of the professional society, clinical practice guide website, Yimaitong website, PubMed, CNKI, WanFang Data and VIP databases were electronically searched to collect stress urinary incontinence management related guidelines from January 1st, 2014 to January 1st, 2019. Two reviewers independently screened literature, extracted data and evaluated the quality of included guidelines using Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) and the characteristics of each guidelines were analyzed.ResultsWe identified totally 8 relevant evidence-based guidelines in this field. The average standardized scores in the 6 domains of AGREE II were 90.74% (scope and purpose), 78.71% (stakeholder involvement), 74.60% (rigor of development), 93.52% (clarity of presentations), 61.81% (applicability), and 91.67% (independence). The overall standardized scores of 8 guidelines were 77.70%, and the total scores were 5.31 (out of 7). For overall quality, 4 of them were grade A and 4 of them were grade B.ConclusionsThe overall quality of evidence-based guidelines for stress urinary incontinence is high, and scores in different fields are vary large. Fields of " stakeholder involvement”, " rigor of development” and " applicability” with lower scores still requires strengthening. The current guidelines for female stress urinary incontinence in China still fails to meet the standards of evidence-based guidelines, so the quality of the guidelines should be improved to improve guide clinical practice.
摘要:目的：探討超聲引導下組織間插植內照射治療中晚期宮頸癌的意義和效果。方法:回顧性分析32例中晚期宮頸癌患者,采用超聲引導下腫瘤組織間插植內照射+外照射。結果：有23例腫瘤脫落,宮頸原形出現,其余7例腫瘤縮小50%以上,持續時間均≥1個月,另有2例腫塊縮小＜50%,即CR為719%,PR為218%,NC為63%,PD為0%。結論：超聲引導下插植內照射是一種治療中晚期宮頸癌的安全有效的近距離放療技術。Abstract: Objective: To evaluate the efficacies of interstitial implant brachytherapy by ultrasoundguided for moderately advanced and advanced cervical carcinoma. Methods: Thirytwo patients with cervical cancer ⅡbⅣ who received interstitial implant brachytherapy by ultrasoundguided and routine irradiation. Results: 719% cases achieved complete remission (CR), 219% cases partial remission (PR), 63% cases no change(NC),0% case progressed disease（PD）. Conclusion: Interstitial implant brachytherapy by ultrasoundguided is an effective method for cervical tumor.
Clavicle fracture is a common orthopedic injury, accounting for approximately 2.6%-4% of all adult skeletal fractures. In 2023, the American Academy of Orthopaedic Surgeons (AAOS) developed evidence-based treatment guidelines for clavicle fractures, which include 4 recommendations and 10 options. This article, based on a thorough review of the guidelines, discusses the clinical treatment of clavicle fractures, aiming to share advancements and the latest diagnostic and therapeutic considerations with orthopedic colleagues to enhance treatment outcomes.
